Ketone Monitoring Approaches for Diabetic Ketoacidosis Risk Mitigation in People With T1D on Adju… (NCT07421518) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Ketone Monitoring Approaches for Diabetic Ketoacidosis Risk Mitigation in People With T1D on Adjunctive SGLT-2 Inhibitors
United States75 participantsStarted 2026-06
Plain-language summary
The purpose of this research is to see how well a special education plan using continuous ketone monitoring (DGK) works to lower the risk of a condition called diabetic ketoacidosis (DKA) in people with type 1 diabetes (T1D) taking SGLT2 inhibitors (a type of medication commonly used to treat type 2 diabetes). This special education plan is compared to a general education plan and considers the higher risk of DKA when using medicines like SGLT2 inhibitors.
Who can participate
Age range18 Years – 40 Years
SexALL
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Inclusion criteria
✓. Men and nonpregnant women ≥18 years and older
✓. Diagnosis of T1D according to American Diabetes Association (ADA) criteria
✓. HbA1c \< 9 %
✓. Participants treated with multiple daily injections of insulin, insulin pump, or advanced insulin delivery systems
✓. Has provided written informed consent to participate in the study.
✓. Must be willing to wear the investigational device
✓. Use of adequate contraception for the duration of the study by women of childbearing potential
Exclusion criteria
✕. Pregnancy, lactation or planning to become pregnant
✕. Any form of diabetes other than T1D
✕. People with T1D using weekly insulin (when approved)
✕. Use of sodium-glucose cotransporter 2 inhibitors within 4 weeks prior to screening
✕. Chronic systematic corticosteroids (\>4 consecutive weeks) within 6 months before screening
✕. History of diabetic ketoacidosis within 6 months of screening
✕. History of multiple (≥ 3 infections) genital mycotic infections within 6 months of screening
What they're measuring
1
Ketone events with Beta-hydroxybutyrate (BOHB) >1.5 mmol/L
Timeframe: 6 months
Trial details
NCT IDNCT07421518
SponsorAdventHealth Translational Research Institute
✕. Hypotension at screening is defined as systolic blood pressure \< 90 and diastolic blood pressure \< 60 with symptoms of low blood pressure (confusion, dizziness, lightheadedness, fainting, heart palpitations)